Study of Dosage Exploration and Pharmacokinetics for HA121-28 Tablets

Summary

There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion).

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of HA121-28 tablets that can be given to patients with advanced cancer. The goal of Phase 2 of this study is to learn if the dose of HA121-28 tablets found in Phase 1 can help to control advanced cancer.

The safety of HA121-28 tablets will be studied in both phases of the study.

Conditions

• Advanced Solid Tumor

Interventions

DRUG

HA121-28 tablets

Participants will receive oral HA121-28 at a starting dose of 25 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle

DRUG

HA121-28 tablets

Participants will receive oral HA121-28 at a dose of 50 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle

DRUG

HA121-28 tablets

Participants will receive oral HA121-28 at a dose of 100 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle

DRUG

HA121-28 tablets

Participants will receive oral HA121-28 at a dose of 200 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle

DRUG

HA121-28 tablets

Participants will receive oral HA121-28 at a dose of 300 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle

DRUG

HA121-28 tablets

Participants will receive oral HA121-28 at a dose of 450 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle

DRUG

HA121-28 tablets

Participants will receive oral HA121-28 at a dose of 600 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle

DRUG

HA121-28 tablets

Participants will receive oral HA121-28 at a dose of 800 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Wen Xu · Clinical Medicine Department CSPC R&D Business Division

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-10

Primary Completion

2022-12-30

Completion

2022-12-30

Countries

• China

Study Locations